Scimed Model Sm-C/Vr Cardiotomy/Venous Reservoir
FDA 510(k) K882380 · Scimed Life Systems, Inc.
510(k) numberK882380
Submission
- Device name
- Scimed Model Sm-C/Vr Cardiotomy/Venous Reservoir
- Applicant
- Scimed Life Systems, Inc.
Minneapolis, MN, US - Received
- June 9, 1988
- Decision date
- October 6, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DTN – Reservoir, Blood, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4400
- Specialty
- Cardiovascular
Other 510(k)s with product code DTN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251783 | Inspire HCR and HCR DUAL cardiotomy reservoirsDTN · Traditional | Sorin Group Italia S.R.L. | 12/22/2025SE |
| K241206 | Quantum Perfusion Hybrid SystemDTN · Traditional | Spectrum Medical S.R.L. | 07/18/2024SE |
| K241053 | MVR Venous Reservoir Bag 800 mL; MVR Venous Reservoir Bag 1600 mL; MVR Venous…DTN · Special | Medtronic Cardiac Surgery | 05/15/2024SE |
| K223361 | BMR 1900 PhisioDTN · Traditional | Sorin Group Italia S.R.L. | 06/10/2023SE |
| K170583 | Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive SurfaceDTN · Special | Medtronic, Inc. | 03/17/2017SE |
| K161733 | Inspire SVR 1200, Inspire 6F C, Inspire 8F CDTN · Traditional | Sorin Group Italia S.R.L. | 03/08/2017SE |
| K153143 | Capiox Advance Hardshell ReservoirDTN · Special | Terumo Cardiovascular Systems Corporation | 12/02/2015SE |
| K151110 | Intersept Filtered Cardiotomy ReservoirDTN · Special | Medtronic, Inc. | 05/27/2015SE |
| K141432 | Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell Cardiotomy…DTN · Special | Maquet Cardiopulmonary, AG | 07/07/2014SE |
| K141233 | Affinity Pixie Oxygenation System with; Carmeda Bioactive Surface, Balance BiosufaceDTN · Special | Medtronic, Inc. | 06/12/2014SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K974241 | Scimed Informer Pressure Wire SystemDQX · Traditional | 11/12/1998SE |
| K981788 | Scimed 6 French Wiseguide Guide CatheterDQO · Traditional | 08/18/1998SE |
| K980360 | Scimed Quest Floppy and Moderate Support Guide WiresDQX · Traditional | 04/29/1998SE |
| K974559 | Scimed 6 French Impulse Angiographic CathetersDQO · Traditional | 02/23/1998SE |
| K974684 | Scimed 7 French Wiseguide Guide CatheterDQY · Traditional | 02/19/1998SE |
| K973945 | Luge Guide WireDQX · Traditional | 01/12/1998SE |
| K970823 | Scimed 8 French Wiseguide Guide CatheterDQY · Traditional | 06/03/1997SE |
| K964551 | Choice Super Support Ptca Guide Wire, Choice Plus Super Support Ptca Guide Wire, Choice…DQX · Traditional | 05/21/1997SE |
| K970244 | Scimed Choice Family of Ptca Guide WiresDQX · Traditional | 03/28/1997SE |
| K965023 | Choice PT Plus Ptca Guide Wire and Choice PT Vision Ptca Guide WireDQX · Traditional | 03/04/1997SE |
Questions and answers
When was Scimed Model Sm-C/Vr Cardiotomy/Venous Reservoir cleared by the FDA?
Scimed Model Sm-C/Vr Cardiotomy/Venous Reservoir (K882380) received a 510(k) decision of Substantially Equivalent on October 6, 1988, 119 days after the submission was received.
What is the product code of K882380?
The FDA product code is DTN – Reservoir, Blood, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4400.